![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
Ludwig Institute for Cancer Research |
---|---|
Information provided by: | Ludwig Institute for Cancer Research |
ClinicalTrials.gov Identifier: | NCT00112242 |
The purpose of this study is to determine whether vaccination with melanoma antigen peptides [Melan-A/Mart-1 (both EAA and ELA), NY-ESO-1b analog, Long NY-ESO-1 LP and MAGE-A10] and Montanide, CpG adjuvants and low dose rIL-2 can induce an immune response in melanoma patients and to assess the safety of this vaccination.
Condition | Intervention | Phase |
---|---|---|
Melanoma |
Biological: Montanide + Melan-A analogue peptide Biological: Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide Biological: Montanide + CpG-7909 / PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide Biological: Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide Biological: Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | Vaccination of Patients With Stage III or IV Malignant Melanoma With Melanoma Antigen Peptides [Melan-A/Mart-1 Analog (ELA), NY-ESO-1b(A) Analog and MAGE-A10] and Montanide Adjuvant |
Estimated Enrollment: | 37 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Montanide + Melan-A analogue peptide
|
Biological: Montanide + Melan-A analogue peptide
1 ml Montanide+ 500 mcg Melan-A analog peptide
|
2: Experimental
Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
|
Biological: Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
1 ml Montanide + 500 mcg Melan-A analog peptide + 500 mcg NY-ESO-1 analog peptide + 500 mcg Mage10 peptide
|
3: Experimental
Montanide + CpG-7909/PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
|
Biological: Montanide + CpG-7909 / PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 500 mcg Melan-A analog peptide, 500 mcg + NY-ESO-1 analog peptide
|
4: Experimental
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide
|
Biological: Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide
1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide
|
5: Experimental
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2
|
Biological: Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide +
low dose IL-2
1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide + low dose IL-2
|
Current peptide vaccines suffer from low efficiency, since they induce only weak immune activation. We have recently confirmed that in humans the immune response was readily detectable in local lymph nodes while no or only weak activation could be identified in circulating lymphocytes. Increased doses of antigen and adjuvant allow a better extension from local to systemic immune responses.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |
Division of Oncology at the Geneva University Hospital | Active, not recruiting |
Geneva, Switzerland, 1211 | |
Switzerland, Vaud | |
Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois | Recruiting |
Lausanne, Vaud, Switzerland, 1011 | |
Contact: Daniel E. Speiser, MD +41.21.314.01.82 daniel.speiser@hospvd.ch | |
Contact: E. | |
Sub-Investigator: Daniel E. Speiser, MD |
Principal Investigator: | Olivier Michielin, MD | Ludwig Institute for Cancer Research |
Responsible Party: | Ludwig Institute for Cancer Research ( Ralph Venhaus, MD, Head of Clinical and Regulatory Affairs ) |
Study ID Numbers: | LUD 2001-003 |
Study First Received: | May 31, 2005 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00112242 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Immunotherapy Vaccination Melanoma Melan-A/Mart-1 peptide |
MAGE-A10 peptide NY-ESO-1 peptide Montanide |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Adjuvants, Immunologic |
Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |